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and david maraniss. >> next we cover a meningitis outbreak that killed 32 people. it is linked to contaminated steroids supplied by a massachusetts supplier. members of the subcommittee criticized the fda for not doing enough to shut down the pharmacy. the faa commissioner testified that her agency lacked the authority to do so. >> my colleagues, we convened a hearing to examine the recent outbreak of fungal meningitis. linked to contaminated products made by the new england
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compounding center or necc. i want to accept and my deepest condolences to anyone who has lost a loved one in this tragedy. thirty-two people have died. including three with in my congressional district, one of the persons who lived right up the street from me. well over 400 people have been sickened for making this one of the worst public health disasters ever caused by a contaminated drug. before this outbreak, with the fda had conducted three separate inductions of inspections with
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necc. but history is even more expensive with necc, involving at least 12 separate complaints involving necc or its pharmacists. since necc opened in 1998, over the course of these inspections, regulators noted the same kinds of problems at issue in the current outbreak. problems with serialization and in violation of its own license. back in 2002, several adverse events were reported to fda involving patients who had received steroid injections made by the necc. fda followed up and inspected it. just six months after the inspection, patients were again hospitalized after receiving necc's injections.
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in 2002, patients displayed meningitis like systems. the product in question was a very safe product connected to the current outbreak. in that case, the necc drug was contaminated with bacteria. after the 2002 meningitis cases, the state pharmacy board met in 2003. they reviewed necc's conduct. during this meeting, the fda made a prophetic statement. they stated that there was, the potential -- serious public health consequences in the compounding practices, in particular, those relating to sterile products are not improved. the fda was clearly aware of the risks posed by necc's compounding practices, the agency was simply slow to act.
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in fact, it took the fda for years after finding problems with the steroid practices in violation of the fda acts to issue a simple warning letter. it took the fda another two years to respond to companies complain. when the fda responded, six years after the agency first inspected the nbcc, they asked the company to correct the violation and one that would follow up with future inspections. but the fda never did so. the fda didn't even follow after the pharmacy the necc was against sending its drugs out of state hospitals without receiving patient prescriptions.
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the fda didn't even prefer to the massachusetts board for follow-up. we are left to wonder what would've happened if the fda had investigated or informed the massachusetts board of complain. it is possible this outbreak might have been permitted. we will get to the bottom of this so that we can ensure this outbreak in things like this never occur again. we are also joined by the fda and commissioner smith and the massachusetts department of public health. i am interested in learning whether they think this could have been prevented and whether their agency stopped it.
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they have a history of conducting bipartisan oversight and this is no exception. it is my hope that this hearing will serve as an opportunity to determine the reasons why such a history of this does not repeat itself. with that, i headed over to german joe barton. >> thank you. i think my time has expired. to okay. >> okay, four minutes. to thank you very much, mr. chairman. i do appreciate you taking the time to have this hearing on the day we returned from the recess. this is such an important public health issue, and we are acting in a bipartisan way. i am also glad about that. the contaminated steroid injections by the new england compounding company have caused
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438 cases of fungal meningitis, spanning 19 states. thirty-two people have died. i'm afraid that number could continue to climb. we have for witnesses four witnesses to help us examine how this could have happened. i am very eager to hear from the fda and also the massachusetts board of registered pharmacies with authority over necc at just how we got here. i would like to hear about how on earth his company could have been so irresponsible, causing the death of so many americans. i am looking forward to hearing from joyce lovelace, who is the wife of one of the first victims in this tragedy. i want to join with expressing my deep sadness for your loss. i really want to thank you today. congressman, thank you so much. i know this is hard for you, but it's important.
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the owner failed to ensure that the necc follow safety guidelines again and again. reports of problems were brought to the attention of the massachusetts board of registration of pharmacy, which failed to act. they were informed of problems and complaints even from its own inspections in 1999, 2002, 2003, 2004, and even this past summer. somehow, necc was able to keep its license and avoid significant penalties and continue its operations until tragedy struck all across the nation. we also need to hear an explanation from the fda. just like the massachusetts
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border pharmacies,. there was a warning letter to the company in 2006. a letter that had very little effect. the fda said they were hobbled by questions about whether they had the legal authority to address the problems of the necc. they need to act quickly on behalf of patients. over 30 people have died from this a meningitis outbreak because too many signals about the risk were mixed. one of those signals come as the chairman said, came from my home state of colorado. in 2011, the colorado state border pharmacies determined
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that necc was distributing unlicensed and unregistered drugs in the state. and they issued a cease-and-desist order. but this was not enough to stop their actions. they notified the massachusetts border pharmacies, and they did nothing. the colorado border pharmacies did the right thing. the system failed. necc did not improve its operation. the fda did not act. massachusetts did not act. now, mr. chairman, for a long time, we have all had sort of a norman rockwell vision of the pharmacist to manufacture the drugs on mainstreet that the families who i am. treating a little child with an illness. unfortunately, this tragedy makes clear that large corporate compounding pharmacies are operating unchecked by appropriate safeguards, even as american families trust them
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with their lives. we need to work together to make sure that this crisis is not repeated. i will yield the remainder of my time to mr. ed markey from massachusetts. >> i think the gentlelady. do england's compounding center is in my district in framingham. my deepest condolences go to all victims and their families. necc was no stranger to federal and state regulators. it has been the subject of the release similar complaints in 2001, 1999, 2001, and 2002. yet, the owner was appointed to the state task force for developing new regulations for compounding. in june of 2006, my report, which i have completed on this issue shows that even before the current outbreak, there were 26 deaths, and other related illnesses with this.
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i want to commit to you and all of the victims that i will not stop until we make sure that these industries are safe. i think you for your courage. we have to make sure that this never happens again. i yield back my time. >> thank you, i recognize the chair of the committee. the gentleman from michigan. >> thank you. when we first began this investigation over a month ago, we do the knew that people were sick and we knew that people had died due to contaminated medicine made by the new england compounding center. one of my constituents, a grandmother from cass county, lost her life to these contaminated drugs. what makes this tragedy worse is the fact that it seems that these deaths and illnesses could have been prevented. the necc was not unknown to its regulators. it was not operating under the shadow of darkness.
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the company has been inspected a number of times since they opened their doors in 1998. the fda even issued a warning letter. the massachusetts border pharmacies entered into a consent agreement with the company that same year. the very same job for the current outbreak, patients have been hospitalized with meningitis like symptoms. ten years later, we are in the midst of an unthinkable worst-case scenario. hundreds have fallen ill. it is inexcusable. today, we will hear from the
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massachusetts department of public health and the fda about their history, and why did they treated the company the way they did. what a regulators still confident that this company can make drugs competently after finding that their drugs were contaminated back in 2002? after being served multiple violations leading up to the fda's warning letter, why did the agency failed to conduct a single follow-up inspection? the public deserves to know what went wrong. i think doctor smith and doctor hamburg are testifying today. the massachusetts board in providing thousands of pages of documents in relation to necc. thank you, doctor smith, for making yourself available to the committee. i wish i could say about the fda
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does same thing. the fda has still not provided this sensitive information requested by the committee more than a month ago. the fda has not provided its communications related to the necc. we need to focus on protecting public health by cooperating. we will insist on a firm timetable as to when and how you can produce those documents. the sooner the fda cooperates, the sooner they can determine what went wrong and what we need to do today to fix it so it doesn't happen again. i yield the balance of my time to mr. joe barton. >> thank you, mr. chairman. there is a saint you can bring a horse to water, but he can't make it drink. you can take a regulator to a
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problem, but he can't make them regularly. we have numerous cases in the last 10 to 15 years of state and federal regulators made aware of a problem with this particular company. and they go out and they ask for documentation, and then they issue some sort of a general reprimand on some cases, and then they do nothing at all. we have to get regulatory authority of the state and federal level. you have to get the regulators to use the authorities -- the repeated instances of walking
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through a scene contamination in the various batches of this particular product. and it has been going on for 10 to 15 years. let's find out what the facts are in and deal with what is necessary to put stop to this once and for all. with that, i yield back my time. >> the gentleman yield back. we recognize the ranking member, the government from california, for five minutes to thank you, very much, mr. chairman. i want to thank you for holding this hearing and working with the democrats to make this a bipartisan hearing. we are talking about this ongoing health tragedy.
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an untold number of vials of steroids were contaminated. they have sold all -- they have so far killed 32 people. it has brought unspeakable devastation to so many families. that is why i am grateful for it joyce lovelace to be here. it takes a great deal of courage to come forward. let's not lose sight of the wrongdoer. the regulators deserve blame. the primary blame is the company. we have theubpoena, the former president necc, barry
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cadden, we asked him to testify about how this company handled the matter. what we learned is that even 10 years ago, people who were regulating the company indicated that they had sloppy practices. in many years ago they indicated that they could have can have a meningitis outbreak. it wasn't corrected by the company. and the company went about its ways, telling people that they were going to behave better. they were going to change their ways. but that doesn't mean that we don't insist the regulators, watching out for the public interest. i am pleased that both sides are talking about the need for regulation on what we need to do to straighten out who has what responsibility to be sure.
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the massachusetts board of legislation, and other state regulators and health care providers, identify the problem with the company. the massachusetts board inspected the facility after the outbreak. they found a horrifying list of problems. those who ran the facility allow this to happen. the board never took action promptly enough to stop the new england compounding center from putting consumers at risk. finally, we have the fda. the fda was informed of the problems and conducted investigations. they raised concerns about the necc. for the most aggressive action of the agency that they took was a warning letter in 2006.
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that letter and previous attempts to inspect and review the actions were met with seven refusals and a challenge to the fda authority. the fda has questioned their authority. congress acted specifically in 1997 to limit the authority of the fda. when there was a supreme court case that left the fda with the authority. mr. ed markey, it's a good start. i think we want to work to pass bipartisan legislation during the lame-duck session that preserves pharmacies abilities to operate safely and appropriately that gives the fda to clear and effective authority to prevent compounds from becoming dangerous drug manufacturers. like the necc. mr. chairman, i want to yield the balance of my time.
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>> the gentleman from michigan is recognized. with the consent -- unanimous consent -- but you can have an additional two minutes. we have an additional two speakers that will speak each a minute apiece after you, if that is unanimous consent accepted. >> i do thank you. >> unanimous consent so ordered. the dean of the house is recognized for three minutes. >> i think you and i commend you for holding this hearing. i am happy with the speed with which the committee has responded. i note that my home state of michigan leads the country in the number of cases related to this fungal meningitis outbreak, with 129 patients affected and nine deaths.
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the individuals and their families deserve answers as to how this was able to occur. we also need to encourage the pharmacies to purchase fake pharmaceuticals. the new england compounding center which has a long history of stability issues and significant other problems was not properly regulated by either federal or state authorities. sitting on the border between the two authorities, they were able to disregard their responsibilities with a bad situation. no one specific prescriptions that were required by the massachusetts law.
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compounding services is an important public service. i am concerned that the necc was operating in such a volume as to be outside what many properly consider traditional pharmacy compounding. instead, being classified as a drug manufacturer and engage in drug manufacturing. one reason we are given on many occasions to all concerned, we will have to see through it without situation does not get obtain. obtained. i would note that we have the classic system of the tragedy of the commons before us. we're what belongs to everybody or more than one, appears to belong to no one. as a result, these agencies responsible for the problems -- neither dealt with the problems.
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i am fearful, mr. chairman, this problem is something that will require very strong legislation. it is legislation that is easily done. i think you for your courtesy. i yield back the balance of my time. >> thank you, distinguished gentleman. i now recognize mr. griffith for one minute. >> thank you so much for holding this hearing. like so many others that have spoken, my area in virginia has been hard hit. we have two fatalities, and i was on the phone this morning with the father of the youngest victim to date in the united states. a young man who just turned 16 when he was stricken down.
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he has the advantages of age, but they don't know what the end result will be on the friday before he was written down. as a sophomore, he ran one back for a touchdown as a great athlete in football. this gives him some him some advantages. but how will his life be changed? we don't know. our job is to find out why this happened. to make sure that it doesn't happen again. and i look forward to working with everyone. i also want to thank ms. joyce lovelace for being here today. i'm so sorry for your loss. with that, i yield to marsha blackburn. >> the gentle lady from tennessee is recognized for one minute. >> thank you. i am appreciative to the manner in which we move quickly so nicely on this issue. we are appreciative that you
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would take your time to join us. according to the cdc, 81 tennesseans have been affected. they have been affected with fungal meningitis and 13 tennesseans have lost their lives. this is something that is of tremendous concern to us. it is because of this. on behalf of my constituents, those who have been adversely impacted by this fungal meningitis outbreak -- i am interested to hear why the fda did not pursue any enforcement actions against the necc. despite nearly a decade ago, nearly a decade ago -- the potential for serious public health consequences were there. these are answers that we are looking for. questions that we approached her and her comments. i look forward to the hearing. i yield back my time. >> the gentlelady yields better
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time. the first panel is mrs. joyce lovelace. she is the wife of the late eddie lovelace. he served in kentucky's clinton, cumberland, and monroe counties. judge lovelace was the first confirmed death as a result of fungal contamination from steroid injections. before joyce lovelace against her testimony, i would like to recognize the distinguished gentle ben from kentucky, who is also chairman. the one who represents the first district of kentucky for an introduction of ms. lovelace. >> thank you very much. thank you to all the members of this committee. we genuinely appreciate you being here to investigate this issue. i feel very fortunate to be here
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with ms. lovelace. ever since i have been a member of congress, joyce and eddie and i have been very good friends. they live in albany, kentucky. we talked about statistics and figures. when you look at the individual lives involved, it makes all the difference in the world. joyce and eddie were married almost 56 years. he died on september 17, 2012, as a result of publications from contaminated steroid injections that caused fungal meningitis. which is the focus of this hearing. he was 78 years old. i might say that most people who met him thought he was 50 years old, because he walked three or 4 miles every day. he was a circuit judge. he was one of the most wonderful scholars in kentucky and served as a chief prosecutor, a county attorney, and he was one of those people involved in every
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aspect of the community of albany. we will all miss eddie lovelace. we will never forget him. at this time, i would like to thank joyce very much for being willing to share her story and eddie is a story with the committee, joyce, thank you so much for being here with us. >> i think that calling for that kind introduction. ms. lovelace, you are aware that the committee is holding an investigative hearing. when doing so, we have had the practice of taking testimony under oath. do you have any objection to testifying under oath? >> no. >> under the rules of the house, we advise you under the rules of the committee coming you, you are entitled to be advised by your counsel. do you desire to be advised by counsel during your testimony today? >> yes. >> okay. in that case, if you are able to stand, if not, then please raise your right hand, and that's where he went.
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do you swear to tell the whole truth, nothing but the truth, so help you god? >> i do. >> you are now under oath and subject to the penalties set forth in title 18 section 1001 of the united states code. we are welcoming you today and you can give your five-minute summary opening statement if you would. >> thank you, mr. chairman. thank you members of the committee. i am very much encouraged by what i have heard from you today. that you do plan to investigate this matter. that it is basically what my family's desire is, to get to the bottom of this, and make sure that it never happens to another family. because we have lived a nightmare. we will be living this nightmare for ages to come. it is something that we will probably never really be able to get closure on.
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because it was just such a useless thing that happened to my husband. i don't have any notes. my husband hated notes. obviously, he can't be here. i'm here on his behalf. so i am just speaking from the heart. i think he you would not want me to have notes. he never read, he always spoke. i was fortunate enough to have been married to have been united to a man that was wonderful for 56 years. i don't think any merit is perfect, but we worked together. we were married when he was impossible. i worked and helped him make his way through law school. we moved to albany. we made our home there. he immediately began to be
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involved in civic matters, community matters, he taught sunday school for 42 years. he was still teaching when he passed away. he was a gifted speaker. i want these people to know what kind of person has perished. because of their lack of concern. my family is better. we are angry. we are heartbroken. we are devastated. i come here begging you to do something about the matter. i cannot say enough good about him. he was bigger than life in any setting that you could put him in. i work in his office and i have
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seen all sides. i have seen him interact with all classes of people. in all situations. and he had a gift of working with people. he was compassionate. he wanted to help the people that needed it. he would give people full consideration. it is ironic that he wanted the victim on us. i can't begin to tell you what i have lost. my soul mate and partner. words can't describe -- we got
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our older children and grandchildren through college. our oldest granddaughter became an attorney thanks to the appreciation for the work that he did. and he had two years left in his term as judge. he planned to complete his term ended going to practice with her granddaughter and help her get started. now, she won't have that. our younger grandchildren have lost the best playmate that they have ever had. he played anything but our grandchildren asked him. they could dress them up, they could do anything.
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in fact, he wanted to do it. they all wanted him to play with them. our youngest granddaughter asked him, will you drive me around and let me read? and he would put her in the car and he would drive and let her read her books. she is now in the sixth grade and an avid reader. these are some of the things that were glorious. he had a brilliant legal mind. he studied the law every weekend on friday. he wanted all the opinions of the appellate courts. that was his weekend -- that was reading.
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if you didn't get it all done, that would ruin his weekend. now, he was a healthy individual. he walked 3 miles every morning before i would even get out of bed. he wanted to stay active. he didn't have the parents of the 78-year-old man until about the second injection. then we begin to see. he had lost his balance, he was stumbling, he failed and began to have headaches, which he never had before. and i was really concerned. i was concerned that his appearance. he had the look of someone who might have cancer. he had a physical examination. maybe two weeks before he fell
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very sick. before he became sick. and they said that nothing was wrong. then the problems he had for kidney stones and allergies, many of which he has had most of his life. on the 11th of september, he began to have numbness in his hand. we begged him to go to the emergency room and he declined. he had bad headaches and he told me that two fingers on his hand were not right. he couldn't use the two fingers. this became what happened, and he would still not go to the emergency room. he was not an individual that was not not said that much, and
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he didn't want to go to the doctor. he just didn't go until he had to. the next morning, he had been up, and when i got up, he had fallen in the kitchen. he had a horrible look on his face. i will never forget the expression. and he says my legs don't work. he said that i have been out twice to get my paper, and i have fallen twice. our daughter is a nurse, and i held her on the phone, and she said get into the emergency room. they transferred him to vanderbilt in nashville. he had had a car accident in march -- the last of march. he had gone through his physical therapy and done everything but the doctors had tried to tell them what to do, in an effort to
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be able to work with them to get back on the job. he was referred to a nurse surgeon at saint thomas. that is where he received these injections. at the same thomas neurological outpatient center. he went to vanderbilt on the 12th. within a day or two, he started declining. very fast and rapidly. his speech became slurred. he lost the use of his hands. he had no hand eye coordination. he could not be himself.
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he just declined so rapidly. on the 17th, he passed away. people, it was not an easy day. these are human beings. the committees, the fda, the necc, whoever is responsible. i want them to know that their lack of attention cost my husband his life.
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it cost us a lot that we will never recover from. if you don't do your job, it may not appear to be anything to you, but you are affecting human lives. valuable human lives. my husband was valuable to us. and i cannot thank you enough, i don't care what party works together. >> we will do so. >> thank you very much for your poignant testimony. i'm just going to ask two questions. when he found out that your husband was the first of many to be linked to these contaminated products distributed by necc, do
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you remember when i was? how long after he died, and secondly, who was it that informed you about this? >> he passed away on september september 17. we went ahead with the funeral services thinking that he had a stroke, because of the diagnosis. on the third of october, i believe it was, we found out that it was from these injections. through the press. my son-in-law was the first that read it or heard about it. on october 6, i received a call from a reporter from the national tennessean, and he told me that a spokesperson at vanderbilt had issued a statement that a 78-year-old man had died from this contaminated
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airwave. >> so you heard about it from the vanderbilt hospital? >> the first i heard was from them. >> no one from the fda or the center for disease control -- did they ever contact you? >> no. st. thomas did not contact me you actually heard about her press report? no one from the state of tennessee? >> i got on the internet, and i called a phone number. >> cu initiated a? no one from outside can you? >> no one. >> even after the press reports? >> no. >> did the vanderbilt hospital doctor call you? >> no, vanderbilt didn't know about it. it was over at the same time.
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on the 25th, someone from st. thomas called my cell phone i asked them what happened. they said they believed that he had a stroke, the next day, another lady called. she wanted to know what his symptoms were, how long he had his symptoms come and whether or not we have had an autopsy performed. neither person mentioned contamination, meningitis, or anything like that. >> with what you say of being a stroke, there might've been people who have died because of the contamination that were
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elderly that were contributed to a stroke. we will never know. my last concern is the effort. the feeling that i have that you had no contact with these other folks i mentioned. i think that if they did contact you, -- [inaudible] those are the questions that i want to ask you. i want to thank you again for the courage to come here. i recognize the ranking member from colorado. >> thank you very much, mr. chairman.
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i just want to follow up with ms. lovelace on some of this. what the chairman was saying, when they went over to inspect fungal necc, they found files with black stuff in them and they found insects near the areas and terrible conditions. we have seen a sometimes with food manufacturers. we say how can this happen in the most allies country in the world. the reason why it is so important, and it is so hard for you, i'm sure, it is easy for regulators and for congress people to talk about this in the abstract. and for everyone being here, there are hundreds of people around the world who have either lost loved ones who were just as
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cherish them as your husband must you, or they are still sick. i also want to let you know that with some of the food safety issues we have identified, we did actually pass legislation. the entire committee, democrats and republicans, we need to make sure that we clarify this. one of the problems, as well as just sloppiness on the part of the massachusetts regulatory agency, the other problem was this gray area. the compounding pharmaceutical
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long where the fda wasn't really sure if if they had jurisdiction . if we do business, which we plan to, we will call you and let you know. >> the gentlelady yields back. we will open the floor for additional questions. just a reminder of the minute that we have. the second panel is barry cadden, the ceo of necc. if anyone would like to ask a question, please go ahead. mr. burgess is recognized from texas to. >> thank you, mr. chairman. we do appreciate you being here and sharing your story with us, ms. lovelace. he made the comment that your husband was very important to your family. obviously, he is important to this committee as well. just like the ranking member, when she was talking about the food safety investigation that we have done, your story, as you are relating it, is so similar to this very room, maybe two years ago, we heard a similar
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story about salmonella in the family actually learn about the loss of their loved one, that maybe it was from the tomatoes in and the salad and wherever it was fun. we read the memos and we understand the litany of problems that existed with this manufacturer. can i just ask you a couple questions to clarify my mind in the timeline that the political course that her husband had, he had the automobile accident, roughly when was that? >> march 30 of this year. >> okay. then his treatment at the outpatient facility for the steroid injection, he had two of those? >> he had three of them. >> okay. so i guess that the last one would've occurred when? >> august 31. >> his illness began?
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>> the 11th of september, but really it was before. >> so roughly, like two weeks? two weeks afterwards. when he was admitted to the hospital, when did that occur? >> it was on the 12th. >> so he had a pretty rapid decline. >> we took him to the hospital and i don't believe that it was in his history. >> it may not have occurred to anyone that. in retrospect, this becomes very intertwined.
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i suspect it is tough for the doctors involved as well, for the doctor that provided the injection and the doctor that provided the treatment, not knowing they were up against. >> i am amazed that they were ordering medicines from someone who had the reputation. >> well, that is part of our problem. that information may not have gone to where it needed to get. we appreciate your courage and strength for being here. anyone have any questions? >> i thank you for being here because of the statement that he made about the importance of the organization involved that is supposed to be inspecting. clearly, they knew that this
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pharmacy have problems. whatever the issue was, surely you have searched so many times and asked, at no time should someone ever say that this is a gray area. the fact that people -- the fact that people do that, it ended up in a tragic loss. i think you for having the courage to be here and put a face on this story. thank you. >> gentlemen, thank you very much. ms. lovelace, thank you so much for your testimony. we think our colleague for his comments, too. with that, we will call up the
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second panel. [inaudible conversations]
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[inaudible conversations]
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>> mr. chairman, barry cadden will rely on his constitutional right not to testify at today's hearing. i believe that this privilege should be personally exercise before the members come as we have done in the past. that is why we have requested that he appeared todore us. i request that given the importance of his testimony, he reconsider his decision to invoke his fifth amendment right. especially because of the families of the people who lost their lives after receiving a contaminated injection, made by his company. those who are sick and those who have received injections, waiting to see if they, too, will get sick or dead they deserve some answers
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today. i asked him to reconsider and telling how this tragedy has happened. mr. barry cadden, are you aware that the subcommittee is holding this hearing, and in doing so, we have a practice of taking testimony under oath? >> [inaudible] >> first of all, mr. barry cadden, we just need a yes or no to the question. put your microphone on. sir, we are asking you if you understand basically -- we have a practice of taking testimony under oath. you understand that? and do you have any objection to testifying? >> no. >> okay. the chair advises that under the rules of the house that you are entitled to be advised by counsel. do you desire to be advised by counsel during your testimony today? >> yes, i do. in that case, would you be so
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kind to identify the council, for a record. >> my attorney bruce single and stephen ross. >> where is mr. ross? comes up from here. okay. at that time, we will swear you in. please raise your right hand and i was wary when. we swear to tell the whole truth and nothing but the truth, so help you god? >> i do. are you one of the owners of the necc, the company distributed contaminated drugs across the country? >> on advice of counsel, i
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respectfully decline to answer according to my fifth amendment right. >> 32 people have died and scores of others injected with medicine that your company compounded are waiting and holding their breath to see they got sick from the products that you made. you have been a director at necc since it opened. you are responsible for ensuring that the product is safe and sterile. ..
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there is no question that was a massive failure of sterilization at your facility. for the sake of protecting the public health and preventing some link like this from ever happening again and to provide some explanation to grieving families, can you please tell us what was the breakdown that led to the contamination and a meningitis outbreak? >> mr. chairman on a vice account so i respectfully decline to answer on the basis of my constitutional rights and privileges including the fifth amendment to the united states constitution. >> are now on now recognize the ranking member for questions. >> mr. cadden we just heard from joyce lovelace.
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joyce lovelace was the first one who was found to have died of fungal mention -- fungal meningitis from one of your companies products. he was a judge, he was a husband of 56 years. he was the father, grandfather and was greg getting ready in two years to leave the bench so he could go into law practice with his oldest granddaughter. there are a number around the country who have either died or become terribly ill as a result of your products. the chairman talked about some of the findings that they found just this year in your company, the greenish black matter inside the files. there were also things like a leaking boiler next to the clean room that created a pool of water which creates a breeding ground for bacteria, and air-conditioning system that turned off at night despite requirements that the clean room had a consistent temperature. your own environmental monetary
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program showed levels of bacteria and mold in the clean rooms between january and september of this year. when fda inspectors look at the sister company, they found the same kind of thing. they reported that there were insects in or near areas where sterile products for package or manufactured. they even saw a bird flying inside an area where where they're supposed to be sterile packages so i guess i would ask you, i would ask you what do you say to all of these patients and all of these families that have been devastated, devastated by these contaminated products that your company produced? >> on advice of counsel i respectfully decline to answer on the basis of my constitutional rights and privileges including the fifth amendment of the united states constitution. >> mr. chairman i think that
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it's clear the witness does intend to exercise his fifth amendment rights and with that i will not ask any more questions and we want have anymore and decide. >> i think the ranking member. led me to the clear mr. cadden again, are you refusing to answer the questions on the basis of the protection afforded to you under the fifth amendment of the united states constitution? >> on advice of counsel i respectfully decline to answer on the basis of my constitutional rights and privileges. >> will you invoke your fifth amendment rights in response to all questions today? >> yes. >> then you're excused from the witness table at this time but i advise you that you remain subject to the process the committee and of the committee needs such then we shall recall you. >> thank you mr. chairman. >> now my colleagues will call up the third panel.
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[inaudible conversations] my colleagues we have on the third panel, commissioner margaret a. hamburg. margaret a hamburg became the 21st commissioner of food and drugs on may 18, 2009. assuming they were less commissioner dr. hamburg was a senior scientist at the nuclear threat initiative. she also served as the assistant secretary for policy and evaluation for the u.s. department of health and human services and is commissioner of the new york city department of health for mental hygiene. we also have the interim commissioner, warren a. smith. lauren a. smith has been the interim commissioner of the massachusetts department of public health since october 25, 2012 and prior to assuming that position served as medical director and chief medical officer of the department.
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let me welcome you to the committee, and let me ask you. you are aware the committee is holding an investigative hearing and we are doing so having the practice of taking testimony under it. do either one of you have an objection to taking testimony under oath? >> no. >> no. >> the chair then advises you that under the rules of the house and the rules of the committee you are entitled to be advised by counsel. do you desire to be advised with counsel during your testimony today? in that case, please rise, raise your right hand and i will swear you in. do you swear to tell the whole truth, and nothing but the truth so help you god? you are now under oath subject to the penalties set forth in
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title xviii section 1001 for the united states code. you may now give a five-minute summary of your written statement. dr. hamburg. >> mr. chairman and members of the subcommittee and aftermarket hamburg commissioner of the food and drug administration and i'm joined by the deputy says he commissioner from regulatory affairs. thank you for this opportunity to testify about the tragic fungal meningitis outbreak associated with an injectable steroid products distributed by zep six as well as safety concerns related to compounding in the legislation that is needed to prevent such events from happening again. i want to begin by offering my deepest sympathy to the patients affected by this outbreak in this families. this event has had devastating effects on patients across the country, such as judge lovelace, many of whom are likely unaware that they were being treated with the combated product not reviewed or approved by the fda.
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our former school is the protection of the health of the public. since the onset of this outbreak targeted resources from experts in our headquarters and inspectors and scientists in district offices and labs across the country to do everything we can. together with the cdc and in the state we have sought to identify potential contaminated products and ensure that they are removed from the market and do not reach patients. it collected and analyzed hundreds of samples from the relevant firms as well as medical facilities and state and local agencies to isolate the cause and determine the extent of the contamination. we are working with timely clear and accurate information disseminated by the findings of our investigation, what products are affected and what dividers should do with any product still on their shelves and we are working to alleviate drug shortages exacerbated by product recalls. we have also been reviewing actions taken in the past with regard to any --
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from our review thus far we have no reason to believe that any of the specific actions and questions or timely issuance of the warning letter or inspections would have prevented this tragedy. what we do know is that stronger, clearer authority would enable more effective regulation of the drug compounding industry, especially when it has been evolving so significantly. as it is, or authority over compounding is limited, unclear and contested and in the face of differing views in congress and the courts about fda's authority and continuing challenges by the industry the agency has struggled with how to chart an effective course to protect the public's health. we recognize the traditional compounding provides an important service for patients who for example cannot swallow a pill or are allergic to an ingredient in a drug product that the industry has evolved well beyond the neighborhood pharmacist. in particular, the movement by
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many hospitals to outsource pharmacy compounding has created a market for compounding operations that produce drugs that reach far larger numbers of patients. when these facilities operate well, they may serve an important function in terms of safety and efficiency. however when they fail quality standards, many patients may be harmed. our best information is that there are thousands of other compound or is out there producing what should be sterile products made to exacting standards and many other firms have the potential to generate a tragedy like this. the current oversight framework and attempt to draw a bright line between compounding and manufactures fails to address the complex issues raised by a change in the industry. additionally ambiguities in the laws have hampered our ability to the protect patients and prevent rather than just react to safety concerns. i'm committed to working with
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congress and other stakeholders to design a system of rational state regulation that takes the federal in the state world. as ali did my testimony, we develop the proposed framework that would carry the degree by the risk posed by the type of products and practices. traditional compounding would remain the purview of this day. the higher risk posed by nontraditional compounding would be addressed by federal standards including standards for quality control and under this framework certain products with the highest risk could not be compounded. they could only be produced by entities willing to meet the standards currently required of drug manufactures. we would like to explore with you authorities it would be important to support this new regulatory paradigm including clear authority to records, mandatory reporting of adverse events, additional registration requirements to facilitate appropriate oversight and coordination with state regulators, clear label
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statements to allow subscribers and consumers the opportunity to make informed judgments and adequate funding to support other oversight activities outlined in this framework. because any plan involving oversight of pharmacy compounded will continue to be made of the state level we must work closely with their state partners as we develop the framework. consequently fda will be inviting representatives from all 50 states to participate in a full-day meeting on december 19 to facilitate these important discussions. we have a collective opportunity and responsibility to help prevent future tragedies. if we fail to act, this type of incident will happen again. it is a matter of when, not if. if we fail to act now, it will only be a matter of time until we are all back in this room, asking why more people have died in what could have been done to prevent it. i am happy to answer any
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questions you may have. >> thank you. dr. smith for the summary of your open statement. >> thank you chairman stearns and make a member to get and members of the committee. thank you very much for having me here today. my name is dr. lawrence smith and i'm the interim commissioner of the massachusetts department of public health. i have to also begin by saying that my -- victims and families affected by this tragic outbreak and to mrs. loveless is moving testimony strengthens my resolve to ensure that no other family has to suffer what she aptly described as the heartbreak. as a mother, pediatrician and the public health leader i've devoted my life and career to protecting health of others. these events have evoked in me the same sense of outrage they do for you and the rest of the public for. for many of you i know this hits close to home. for the past two months our department along with the fda have conducted a joint
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investigation of new england compounding center, the source of this devastating fungal meningitis outbreak that has sickened hundreds and killed 31 people across the country. we have also investigated and shut down necc sister company. necc knowingly disregarded sterility test prepared medicine in unsanitary conditions and violated the pharmacy license endangering thousands of lives as a result. necc there is the responsibility for the harm they have caused with these actions. i was given the responsibility of interim commissioner less than three weeks ago to leave my department -- leave my department and like you i've been trying to put together the pieces of the puzzle. first license for massachusetts in 1998 necc and its owner barry cadden have been the subject of numerous complaints resulting in a series of investigations by the state in the fda. these investigations led to the
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border pharmacies proposed reprimand and probation in 2004. this proposal was inexplicably weakened in 2006 allowing necc to continue operate without disciplinary action pending an independent evaluation of its progress under a consent agreement. the board of pharmacy's failure to take decisive disciplinary action in 2006 on these complaints has contributed to these tragic events. in april of 2006 the board of pharmacy staff learned that the principle and they evaluate her for necc have been convicted of federal crimes that resulted in 18 people being blinded however the staff did not share this information with board members before they accepted the report validating necc compliance with a consent agreement. the same staff members failed to act on a july 2012 report from the colorado border pharmacies that necc violated both colorado
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and massachusetts pharmacy regulations. the staff have been removed from their jobs. poor judgment, missed opportunities and a lack of appropriate action allowed necc to continue on this troubling path. we acknowledge that these lapses some of which were preventable but on where -- all were acceptable. our department acted swiftly and decisively insecure to surrender of agencies licenses, shut down its operations in horse to dorset total recall of all necc products. we moved to permanently revoke necc license as well as the licenses of the key principle pharmacist who oversaw their operations. we secured the suspension of operation for two other drug manufactures owned by barry cadden which as you know have been found to have similar substandard practices. while taking a strong and necessary action we re-examine our state regulations.
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although where regulations are comparable to those in those states they need to be strengthened to address the realities of this evolving industry. on november 1 come massachusetts enacted a series of emergency regulations to bring greater scrutiny to the industry and require sterile compounding pharmacies to report both volume and distribution information to us. licensed pharmacies will have to report any state or federal investigation. we have also begun inspections of all sterile compounding in massachusetts. teams are conducting these inspections as we speak. to further oversight we must look at changes in love we have created a commercial commission to review best practices in other states and to identify stronger mechanisms for oversight for these pharmacies in massachusetts. as we work to raise the -- in and are stably urge congress to act to strengthen federal
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oversight. congressman markey your leadership on this issue is laudable and what addresses the regulatory black holes that exist between state and federal oversight. as a pediatrician who has cared for acutely ill children and their families for almost 20 years, i must say that i understand the trust the patient's place in our health care system. we must use these tragic event as an impetus to work together. public health leaders, public health officials and legislators to issue reforms to restore this and ensure that something like this does not ever happen again. we will keep the victims and their families always in our thoughts. they are not numbers, they are not statistics but real people with real lives. as we work to identify responsibility and to implement policies and practices that are effective and lasting. thank thank you. i appreciate the committees interested in this matter and i'm grateful to you for acting so swiftly to have us come here
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to discuss it. >> thank you dr. smith. commissioner hampered the title of this hearing is fungal meningitis outbreak. could it have been prevented? now your testimony is 16 pages long. there is one sentence on fda's oversight on the new england compounding center prior to the outbreak. now this is an investigative hearing. this was a complete and utter failure on the part of your agency and dr. smith and her testimony admitted in the state border pharmacies. the committee's memorandum that we did, we had 25 pages laying this out gets you devoted just one substance to 16 pages in your opening statement that even talked about this oversight. over the years the fda repeatedly, repeatedly documented numerous problems at the necc. many of these problems are similar if not identical to the
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same problems that caused this outbreak. the agency ultimately issued a warning letter in 2006, six years ago, stating that if the company did not alter's practices the fda would cease its product or issue an injunction and effectively shut down the necc. you heard her testimony this morning. she talked about the mistakes they made and what they are doing to correct it. you are practicing plausible deniability is what you are practicing. when the fda should the 2006 warning lover -- to seize the drugs and shut down the company? yes or no. >> i think it's important, the fact is -- it did not involve sterility failures and it was not in relation to the kinds of
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problems we are addressing now. >> so you are saying your letter was an empty threat? >> i think one of the great challenges -- >> the real question is, not your letter personally. >> is important to understand that i was not -- >> i appreciate that and i understand it. >> the warning letter and the inspection had to do with a different set of concerns. >> let me rephrase the question. do you think the fda had the authority to shut down necc, yes or no? >> i think it's a very complex question. the legal framework for fda activity -- >> if you are not going to answer the question -- she is not answering the question mr. waxman. i have asked her yes or no and she will not answer the question. my question can be asked and you can ask a question. >> i think the answer to your
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question is that even on much smaller regulatory actions the fda authority to act was contested even going into necc to do that inspection 2004. >> let me interrupt you. i'm asking the question and i only have so much time. you issued a letter in 2006 and he said were going to shut them down if they didn't improve on the quality assurance. was at an empty threat? >> the fda think they have the jurisdiction and the responsibility to shut it down? >> the warning letter concerns first and foremost the issue that had to do with making copies -- >> we have a different interpretation of my question. at me interrupt you and ask another question. when the fda -- necc there was evidence people had been infected by contaminated necc products. so those people were experiencing meningitis like
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symptoms. would prove to the company provide then that had had corrected these problems? >> as they think you understand from the documents he provided and the information that has been discussed, we went in and found problems and worked closely with the massachusetts pharmacy to address them but it was determined that the primary responsibility for overseeing necc was massachusetts because they were operating -- >> you are differing to the state? >> we worked with the state and tried to provide health insurance -- assistance. >> before the current outbreak the last time fda inspected the necc was in january 2005, which led to the warning letter. the warning letter stated the fda may conduct follow up inspections to ensure that necc
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was in compliance. there was not a single follow the inspection that occurred after 2005. is that correct, yes or no? do you want me to repeat the question? there was not a single follow up inspections that occurred after 2005? >> we did not do it. >> okay, that is a guest. >> i was not present at the time. from my understanding and i cannot speak to all of the issues that were involved. >> you are taking my time. violation upon violation in 2002 through 2005, wide did the fda feel confident that the necc would correct its violation? >> you had from 2002 to 2005 all these violations. what made you think they would correct it? not you personally. >> in terms of the sterility issues, we acted aggressively in partnership with the state of
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massachusetts, but the day-to-day responsibility for overseeing the practice and remediating the sterility failure were taken on by the state of massachusetts who has the primary day today oversight of this compounding pharmacy, is sent -- and a consent degree was reached in 2006 and we understood as has the massachusetts board of pharmacy that they were properly addressing those sterility concerns. we had gone in relation to a different complaint from a company about the copying of an fda drug and in that instance, we went in relation to the manufacturing of a specific product. it was not an issue of sterility failure or the conditions and the sterility but it was a practice that we felt they should not be pursuing and that
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was what we were trying to address. >> my time has expired and i have recognized the ranking member from colorado ms. do get. >> thank you very much mr. chairman. dr. hamburg i am trying to figure out what's going on here so i would appreciate short answers. most of the fda inspections into this manufacture, necc for about 10 years ago, correct? and that was the fda under the bush administration, correct? >> that that is correct. >> in 1997 i was actually here than. the fda modernization act excluded -- well it excluded drugs -- for the most part. is that correct? >> it is correct. the pharmacy was operating in
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conformance with certain conditions they were not excluded. >> after the 1997 act was passed, when the fda received complaints about drug compounding it had to go over the hurdle of determining whether those conditions had been met or not before the fda was determined it did not have authority, is that correct? >> correct. >> so what happened here is that the fda was contacted in 2002 about the problems. they went into necc and i found some problems than ever as a whole series of investigative efforts after that, correct? one of the issues in this case and in other cases was whether the fda even had authority to be investigating complaints, whether or not this particular manufacture fell under the appropriate criteria, right?
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>> with respect to the public health threats identified in 2002, we went in and aggressively investigated and worked with the state of massachusetts to get those contaminated products to prevent ongoing damage to patients and then because it was a compounding pharmacy the primary responsibility for oversight resting with the massachusetts state board of pharmacy, they were responsible for the effort. >> who is they? >> massachusetts. >> massachusetts was primarily responsible for the compounding pharmacy. all right, so in other cases, not particularly necc but other cases where the fda tried to assert jurisdiction over compounding pharmacies in similar situations they were actually sued in court. the fda was sued in court by companies that the of d.a. did
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not have jurisdiction over these pharmacies, correct? and in fact there is a court case that covers part of the whole country that says the fda does not have jurisdiction. is that right? >> the problem we have today is there's a patchwork of legal authorities that really oversee regulatory actions that we can take. we have a split circuit court decision. there is a map that we have that shows that you know, unfortunately we have unclear, fragmented legal regulatory framework that makes it very hard to understand how best to exercise -- >> in an emergency like this, if you have an emergency like this, sometimes what you are afraid of is you are going to act aggressively but you are afraid you are going to be hauled into court and that is why oftentimes
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you go to the state regulatory agency. >> absolutely. the fact that we have unclear, limited and contested authority and the ambiguities in the law and the crazy quilt of legal authority has required us to be very reactive responding to those serious public health threats and of course every effort is resource intensive as you say and in willen.-- >> so let me ask you this. if congress clarified what we meant in the 1997 act with a large compounding pharmacy that we indeed gave the fda jurisdiction that will help you be able to protect the patients better by either doing inspections to prevent these problems in the first place or by firing quick recalls. is that correct? >> absolutely. >> i just want to ask a really
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quick question of dr. smith. i really appreciate the efforts that you are making since you took over but again most of these things that happened and in fact all of these things that have happened, happened before your tenure dr. smith and i guess i would like to know and in then reading all the documents and all of the history of this, it is obvious to me that the ball was dropped and dropped in a big way by the massachusetts regulators. so my question is, what is massachusetts doing now to make sure this never happens again? >> i agree with you that there were certainly missed opportunities and lapses in judgment that demonstrate significant irresponsibility and we have taken action with the staff that demonstrated that. in terms of what we do now, i can highlight the enactment of emergency regulations importantly which would allow or require the sterile compounding pharmacies to produce information regarding volume and distribution. the volume issue being important
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because if you are making numerous batches, thousands of files and effectively you are acting more like a manufacture than the more traditional compound or. we also require pharmacies to provide information on any state or federal investigation that concerns them. that would allow us to have known that your state order pharmacy had in fact issued a -- to necc in april of 2011 with the same issue of finding bulk prescriptions that were not patient specific and lastly, the convening of a special commission to really understand what are the best practices in strengthening the oversight of this evolving industry. we clearly are committed to making sure that this doesn't happen again and we want to do everything in our power. >> thank you very much and
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mr. chairman appreciate your indulgence. >> the general from from -- the gentleman from michigan. >> thank you mr. chairman. i want to remind you that this committee has a very long tradition, even before john dingell of working with members to identify problems in this country and to expose that and then coming back with legislation to fix it so it doesn't happen again. and one of those is, as we'll review this case, to see what was there in the recent inspection and the black particular, leaking boiler, the bird flying around, just what gives? if this was found just recently and it's our understanding is
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there are similar types of contamination in earlier years, what is the problem, what is the problem by not shutting down something like this until it is corrected and if you don't have the authority, been waiting to make sure that it's there. it seems reasonable to me that in fact he did have the authority to not only have unannounced inspections but to come in and corrected so that it didn't get to this stage. certainly with the deaths of people across the country and the questions that are raised today. as part of the tradition of this committee we have to have the right information and i guess one of the concerns that i have is the bipartisan letter that was send nearly a month ago, we asked the fda for documents for internal communications to find
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out what discussions were going on, what was the feedback from the company and it is my understanding that today we have got some e-mails that have come back but not anywhere close to what we have to have as we really try to move an investigation forward and try to get to the very bottom of this and make sure that it never can happen again. i would ask commissioner hamburg if we can have a commitment from you as it relates back to the letter that we sent on october 17, that we then we get the full cooperation from your staff so that we can come back and ask questions and really tried to get to the bottom of this to identify where are the problems. clearly they were there, right? >> we will work very hard with you and we appreciate the work this committee is undertaking. we have tried to get you the
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documents in a timely way. we have so far been able to get you thousands of pages of documents but unfortunately we are also are suing the act of public health investigation response in many the same people that are involved with the right expertise and knowledge of the issues are working on bad at the same time we are trying to get you that information and of course as congresswoman to get pointed out, this concerns activities, some of that going back many years to a different administration and different employees at the fda so we are going through trying to get all of those documents and we will be continuing to provide you with the information you have requested. >> i just want to say i had a long discussion last month during the break with my colleague from michigan mr. dingell. very frustrated about what was going on and wanted to get to the bottom of this and wanting
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to, as we all think about the fda's proper role, this would be it. as we all identify facilities in our own districts i know that when i go visit it is clean as a whistle, it really is. people are proud to have the jobs that they have, and sterile as you can imagine and i can't for the life of me as we read about this information from eyewitness accounts and inspections that were there before, and to have a go on and on and on without a follow-up and without a -- that is not what anyone is expecting the fda to do. it needs to stop. as americans we demand that poor manufacturing here. we also expected to happen overseas. your inspections in china and other places, the products that
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are being produced are saved not only for americans but for all. you know we get terribly frustrated and i know you tried to, yesterday afternoon and it was my first day back. we will continue to communicate i can assure you that we want to get to the bottom of this. we want to find out what really did write down and where are the questions that have to be answered so that in fact you do have a baseball bat to go after these companies that it's not right. and this is not going to be the last hearing because we don't have the information that we need to receive. so i would like to, and i know my time is expiring that we would like to get a commitment from you that impact will be totally responsive to the questions that are asked by republicans and democrats so that we can figure out where this train got off the track so that we can put it on and we can
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assure every person that in fact the fda is working as it should and we shouldn't have to hear the stories that we did earlier this morning by mrs. lovelace and their constituents, whatever state they are and. i would like to get that from you and i assure you that this is not a one time deal. >> you have my absolute commitment that we will continue to work with you in all of your requests for additional information. you have also touched on a very important point that i want to underscore it though which is that we have a responsibility or oversight of manufactures and drug facilities in this country and around the world, but our authority to provide oversight of drug manufacturers is very different than our authority to oversee compounding pharmacies, which are in fact exempted from important aspects of fda law and you know there is there's this disconnect between different
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legal requirements in different parts of the country as well. we have ambiguous, fragmented, unclear and contested authority in this particular realm of pharmacy and drug manufacturing practice and that is what our opportunity is now and what our responsibility i think is, to work together to really create new legislative authority that defines the best approach approaches, that gets us broader authority that we need to address this growing arena of what we call nontraditional compounding that involves larger volumes, more complex products and sterile products and broader distribution potentially putting more patients at risk and there are gaps in the oversight authorities of the state who has
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primary responsibility for overseeing compounding facilities in the fda and we need to make sure that we have the seamless system that protects the patient. >> the gentleman from california mr. waxman. >> thank you mr. chairman. i think this committee needs to respond on a bipartisan basis and i think we need to correct the law but we have to try to do it before we leave at the end of this year. for this reason. as we get into the next year, some of these interest groups will gear up to stop legislation. they'll say we don't need to have the fda look at these compound or, fda regulates manufactures in the compound or serve going to be regulated at the state level. you are being criticized dr. hamburg as the head of the fda for the problems that were primarily the responsibility of the state of massachusetts. often we hear on this committee,
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really should let the states handle things and not the federal government and in fact i want to address specifically for you in fda you are in a no-win and situation. in the fda asked for more data to determine whether a drug is safe and effective for takes enforcement actions for violations of good manufacturing practices, the agency is accused of being a job killer, no for regulator. now with something terrible happening, we share the something went wrong and everybody is quick to jump on you for not doing enough. now we expect you to do more, we had better be sure that the statutory law that gives you enough authority to do your job if we want you to do the job and not the state do the job. and that may be very critical of the state. the state of massachusetts to drop the ball. they entered into this consent agreement with the company and
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said he walked together an independent inspector. so the company hired an independent inspector and then the independent inspector came back and said everything is fine. then there was questions about whether this is really an inspector that was -- which is a good thing to keep in mind when we say the company decide to the pick to investigate this. let's look at what we can do now. how many compounding pharmacies are there in the united states? >> you know we don't know the exact number because they are not required to register and so you know we are really uncertain but there are thousands of pharmacies that use compounding and we think there are about 7500 pharmacies that do so-called advance compounding and about 3000 facilities that are doing sterile compounding. >> compare that to manufacturing and there is no question you have jurisdiction to inspect the
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man to approve their drugs and recall their drugs. how many manufactures are there in the facilities compared to the compounding facilities? >> you know there are about 5600 manufactures that we provide oversight for, including regular inspections and there is a broader array of facilities that we also oversee in that context. >> the 1997 congress attempted to codify and sda written atari system with respect to the compounding pharmacies but then the supreme court later invalidated a part of that law raising the question of whether the rest of the law is still enforced. sum of argued the fda still has the ability to cobble together other authorities to act in a tragedy caused by necc are ercolino that was a realistic
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possibility or not but what i do know is that the very least there is a dangerous lack of clarity in the fda's authority here. we should fix that. >> i think there is an enormous lack of clarity and i think we should be using this opportunity to address that. >> what authority and enforcement tools does the fda need to better enable you at the fda to take effective action when you discover problems with these compounding pharmacies? >> we feel there needs to be a risk-based framework that enables us to play our critical role in overseeing drugs that are going to the american people. compounding has an important role in addressing medical needs and traditional compounding is probably best overseeing at the level of the state so it should always be undertaken by a licensed pharmacist or physician
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and in accordance with a prescription for a patient for -- gets this area of nontraditional compounding where we think really there needs to be focused attention and new legislation. >> all pharmaceuticals are compounded don't need to be regulated by the fda in the traditional way we think of it. it's a pharmacist putting together the prescription for somebody who has a special need that now we have an example of a company that is shipping it all over the country. they are like a manufacturer of the drugs. what we need to do is very specific authority that you must have to be able to do with this. the second thing we need to recognize is your budget. if we give you authority and there are thousands of compounding pharmacies your agencies, can't imagine have the resources to regulate every single one of them and we need to --
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you need to rely on the state to complement the fda's oversight. is that a fair statement? >> that is a fair statement and with respect to the authorities, it is did outline in the testimony but we clearly believe for a nontraditional compound or there should be federal standards that would establish the safety measures including sterility to be enforced by the state or by the fda and those need to exist and then we need standards to authorities around registration so we know who is out there and what they're making. we need to have records. >> you're absolutely right and i want to say mr. chairman in the records to all in this committee we have to get the right balance and we have to do it before we leave at the end of the year and make it very clear that we are not just saying you are at fault or somebody else's at all. we will be held responsible as members of congress to make sure the law is clear and the agency
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will have the ability and resources to do the job that everybody expects you should've done and we want to make sure you are able to do it. >> the gentleman's time has expired. the gentleman from texas is recognized for five minutes. >> thank you mr. chairman. we have a tragedy of significant proportion. 32 people have died in probably more well. we have got a bipartisan investigation with this subcommittee and we understand that you no business as usual is not acceptable. having said that, apparently the fda has decided this is something that they can used to be able to get more authority to regulate and expects certain transactions that compounding pharmacies do. if there really is a lack of
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regulatory authority at some level, then that is legitimate policy recommendation. if there is not a lack of regulatory authority in the state and federal law right now, then it's unnecessary. my first question is to both dr. hamburg and dr. smith. are you all stating that under current state and federal law, the fda had the authority to seize these drugs or shut this company down? >> i think it's important to understand -- >> i don't need a long -- i think it's important. either the state of massachusetts doesn't have the authority in the fda doesn't have the authority, that is one thing but we have a warning letter, 2006, issued by the fda
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and this was before you were the commissioner that says failure to promptly correct these deviations may result in additional regulatory acts without further notice including seizure or injunction against you and your firm. so, in 2006 with the fda's warning letter, it was the thought of that time that the fda had sufficient authority and dr. smith on behalf of -- she has only been on the job three weeks so we can't hold her liable for what happened you know 10 years ago or six years ago or seven years ago but i don't think there is any question that massachusetts felt there was a violation that they have the authority to shut it down. i think we ought to work on using the authority that we have as opposed to trying to get additional authority at the federal level.
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the fda went in and inspected this particular company on at least two different occasions and as far as i can tell at the venue sharing one warning letter, didn't do anything. at all. >> the truth is that in the initial inspections we worked very closely with the massachusetts board of pharmacy which has the responsibility for licensure and oversight on a day-to-day basis of compounding pharmacies. to make sure the contaminated product was recalled and not continuing to put people at risk is our first priority. >> you are saying the fda did have the authority or did not have the authority? >> we work closely with massachusetts who had the primary responsibility. >> either you do or you don't. >> i think what is very clear -- this be what is very clear is
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that you don't want to answer the question. >> is complicated, but the responsibility is different when the fda has clear and strong responsibility -- >> let me ask dr. smith. >> they are held to a different standard. >> does your state have the authority to shut this company down if you see a clear violation of the law, yes or no? >> yes it does. >> thank you. >> the state has the oversight responsibility for compounding pharmacies on a day-to-day basis. the fda has a different set of authorities and the challenge is that these authorities as evidenced by that map are fragmented and what enforcement actions we can take have to be seen through different lenses in different parts of the country.
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>> i am going to try one more time dr. hamburg. under current law, the food and drug administration administrations of the united states of america have authority over adulterated drugs? >> we have authority over adulterated drugs and we take action related to that. >> thank you. >> by unanimous consent so ordered. >> i would be happy to yield to my good friend, the gentleman from michigan. >> i think my friend. commissioner, to agencies, the massachusetts agencies did not do its job. i don't want you to be defensive but i just want you to recognize a hard fact perker your agency did not use your power to define who is a manufacturer. or you here you have gotten
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agency that has sold over 17,000 -- in something like 23 states. don't you have the authority to define who is the manufacture and who is a compound or in if you do what you do at? >> the problem is the current legal regulatory framework says either you are a compound or a manufacturer. >> he you have that authority. you did not do it. >> my concern though is that if it's all or nothing that way, then these facilities, they were if they were defined as manufactures -- >> we are trying to solve the problem. this is not an issue where you are here to defend yourself. if you choose to do that you are going to have a very hard time on this committee. we do not tolerate that and i will assure you that you're putting your head in the news. i would urge you to cooperate
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with us and give us the answers that we need. >> if i can reclaim my time and recognize where we are. we had unanimous consent to give mr. dingell one minute and because -- >> i'm just going to finish up. i want to be explicitly clear. is there really is a regulatory gap, based on the record that i review, and i don't believe there is but if there is, i suggest there is a bipartisan coalition on this subcommittee and full committee that will move legislation to correct it. is however there is no regulatory -- i think there is a bipartisan coalition on the subcommittee and the full committee to work to make sure that the state and the federal agencies and the jurisdiction work together to solve this problem and to prevent it from happening in the future. with that mr. chairman i yield back.
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>> i yield back and i want to thank the house of representatives dean for taking initiatives to really get the commissioner to answer the question that mr. barton and myself and others have asked then whether you have the jurisdiction i think the answer is yes. you are recognized for five minutes mr. dingell. >> commissioner i would appreciate yes or no answers. do you have sufficient authority to inspect compounding authority of pharmacies, yes or no? >> no. >> we please submit to us it to us what authorities you need so that we can see that it is done? do you have the authority to access all records when inspecting a compounding pharmacy, yes or no? >> no. >> please submit to us the information on what you need so that we can see to it that is given to you? do you have authority to require
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compounding pharmacies to register with the fda, yes or no? >> no. >> would you please submit to us the authorities that are needed so that we can address that problem? do you have the authority to require compounding pharmacies to report adverse events through the fda, yes or no? >> no. >> would you please to submit out us what authority you need in that area? you heard earlier my question about whether or not you have the authorities to define who is a compounding pharmacy and who is a manufacturer. do you have authority to do that or not? yes or no? >> yes, at a very technical level. >> if you need reform or that authority please submit that information to us. commissioner t. have the authority to require come
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posit -- not compounding or something equivalent to good manufacturing practices? >> no, we do not. >> would you please submit it to us the authority that you require? now this question to both you and dr. smith. do you have sufficient authority between your agencies, state agencies and the federal agencies to assure that you are able to coordinate your authorities and to achieve the necessary controls over both manufactures and compounding pharmacies? >> i believe we do not. >> you do not. what is your view on that dr. smith, yes or no? >> we don't regulate or oversee manufacturing. >> okay, but can you define a
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compounding pharmacy? so that you can define your authority? a major problem fell between the cracks. please submit the answer to us for the purposes of the record. now, to get to the commissioner, do you have authority to require compounding pharmacies to indicate on the label of their products could product was compounded and not approved by fda, yes or no? >> we do not. >> would you please submit the authority that unique? commissioner, does not sound like to me that the fda has the authority to oversee compounding pharmacies as a question to define who is a compounding pharmacy. do you have sufficient authority to oversee compounding pharmacies now, yes or no?
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>> we do not, no. >> please submit to us your suggestions for that authority. would you submit to the committee any additional authorities that i have not been able to define here this morning that we should address to you? commercial and are -- commissioner hamburg your agency received two letters dated 2,002,012 regarding this situation. when will you submit to us a response to those letters so that we can have that information available to us as a committee? >> we will get you those responses. >> as soon as possible. mr. chairman, with thanks a return your 24 minutes. one more question.
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those two letters, i would have thought they'd be inserted in the record and the response that will be received. >> by unanimous consent, so ordered. and i thank the gentleman from michigan. the gentleman from nebraska is recognized for five minutes. >> thank you mr. chairman. i want to follow through on some thing -- mr. dingell's question because i think that is at the heart of trying to figure out where the jurisdiction lies or does not roll with the fda and our world. ..
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of why it was put in the states and are best able able to do that. so now, when we focus on the new england compound to center, in native code itself compounding center, but it was a large manufacturing. we know that for its past violations that have come through the attention of both the state pharmacy board and the fda in the past. so we then have the 2011th incident in denver, where pilots
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of the truck was found. a colorado board of pharmacy's issues be cease-and-desist. so now what we have is not manufacturing of a specific job for nonspecific people. to me that is the definition of manufacturing. so honorable hamburg, is the issue that the definition of manufacturing within that bill isn't clear enough for the fda because it seems pretty clear if you're mass-producing condescending to interstate commerce and it's not very specific patient that is not compounding, that is manufacturing. >> i think this has been an evolving history in which you have a problem that exists in
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and authority -- but the honor of >> living in a rep to you because you talk over us. i'm looking for the specifics and the law that say there is lack of clarity on the definition of manufacturing because that seems to be what you're putting your hand on. can you specify in the act that we have to tighten the definitions? >> currently, as we've discussed, there is huge disagreement about the fda authorities and the courts have split -- >> re: tightening the definition of manufacturing? >> the problem is that this evolving industry, they are is a great area. if we would to regulate the
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thousands of compactors. >> can you refer me to the part of this that she would need to focus on, yes or no? >> i'm sorry -- >> refer me to the appropriate part of the statute that? the clarity of which you complain. >> the fda has the authority to act against >> manufacturers. >> oversight of drug manufacturers and with that comes a side effect committees that do not apply to calm ponders -- >> one last question. this is very frustrating. dr. smith, you're in a really tough place to be done a great job. you presented well today, but i'm very curious, without the knowledge that was brought to
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the state board, a colossal failure here. you said you were looking at putting the pieces together. i'm curious is there an evidence of a special relationship the state award in this manufacturer? it seems like somebody is covering for somebody. >> well, we are as concerned about the missed opportunity as you are and there are numerous episodes of that. we're in the process, as i said, of reviewing just that her interviews and the exhaustive document we are doing interfering documents into the community and the thousands of thousands of pages. so i don't know the answer to your question --
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>> last five seconds, honorable hamburg comic in your testimony at 1:30 a.m. for most of us are sleeping on premise of the full purposeless to not let her see her testimony. i yield back. >> the gentleman from massachusetts is recognized for five minutes. >> thank you, mr. chairman. i have introduced legislation to give the fda authority to define which compounding pharmacies should be required to register his manufactures would you support that? >> we think it's important with additional legislation in this area and that calm ponders in fact register and can define what they are doing, what they are manufacturing in the appropriate regulatory oversight would be. >> i've interest legislation to give the fda authority to require compounding pharmacies to compensate strengths using safe practices.
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would you support that? cannot i do support that. >> i conduct the same inspections and request the same documents from the manufacturers who do support that? >> it's enormously important if the authority authority to go and undo full inspections and review documents, collect samples, et cetera. >> have introduced legislation that submits reports of adverse reactions or safety problems to the fda. do you support the da? >> it is currently a cap for adverse events are not required to report for compounding pharmacies. >> i've introduced legislation to require compounding drugs to be labeled. do you believe that authority should be given to click >> yes, we do. >> i may say the legislation also allows traditional compounding pharmacies commences
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, those doing individual doses to individual patients continue to say under state jurisdiction. do you agree with that? >> traditional compounding, one patient, when prescription should be overseen by a licensed physician or pharmacist, but does not require fda oversight. it's nontraditional compounding area, where the volume is larger, distribution is larger, products are more complex or we think we lack the authorities that we need and we appreciate you are introducing legislation and will work actively with you in order to achieve this important goal. >> i think it's critical to today's hearing and what we've heard from the witnesses, the pain that it is caused, the regulatory black hole obviously has to be close to mentally pass legislation to give you authority so children will have
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to look to the history books to find every such a catastrophe suffered by hundreds of families across the country right now. i just hope we can move quickly on legislation to give you that authority because they think you're the cop on the beat and we have to make sure you have the authority which you need in order to enforce the law. dr. smith, i want to commend you and governor patrick for the decisive manner in which he responded to this tragedy. you've undertaken an aggressive investigation and help the companies involved in some members of your staff accountable and put in place stringent emergency regulations for compounding pharmacies in massachusetts. we have learned that this tragedy was enabled a regulatory black hole that allowed a drug manufacturer to masquerade as a pharmacy producing massive amounts, quantities of drugs with little or no federal oversight and able to sell these
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files all across the country to dozens of state without full federal regulation. there were complaints that the reported bizarreness 10 years ago, starting in 1999 with the first complaint from state regulators repeatedly failed to take strong action such as withdrawing necc's license in 2006 c. at the state even wait the company's proposed probation as long as they got a clean bill of health from an independent evaluator. when the same independent evaluator was convict did as selling unsafe medical sterilization equipment that blinded 18 patients, massachusetts did nothing to make sure the clean bill of health by the new england compounding center received was re-examined. dr. smith, have you determined by those decisions were made back then through interviews
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with the staff there at that time? >> now, we have not. we've done interviews as you allude to them we have not been able to really understand why they made those decisions. in retrospect, clearly they were missed opportunities for the board of pharmacy is 2.92 to six to take decisive action and it did not. we are trying to understand that, but we don't at this point. >> perl does documents from that. available for review? >> yes, we produced for the committee thousands of pages of e-mails and those are all being reviewed. >> is it possible some of those e-mails and documents have been destroyed in the period of time from 2006 and prior to today? >> i wouldn't be sure of that. i can say the numbers i've seen also in the earlier prior years
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are prior to what we've seen recently. >> so massachusetts is in the very near future going to have the strongest compounding pharmacy regulation in the country? but that does not protect us from other states having week last-second so compounded drugs into massachusetts or the other 49 states. sieges hit the list of powers, which i asked dr. hamburg if she would support giving to the fda. do support giving to the fda that same powers so they can be the national cop on the beat to protect against one state becoming the place where a rope compact her terraces and harms the rest of the country click >> absolutely. >> i thank you it i thank you all and i thank you, mr. chairman. >> thank you commenced on them. i recognize that are purchased
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for five minutes. >> i think a share for the recognition. dr. hamburg community statement in response to another members questioned that she favored risk-based system. >> let me stop you. this company was bad news from the day it started in the 90s. from my understanding, look at materials provided, they shipped preprinted prescription forms to various clinics around the country, a clear violation of what they should be doing. you have come the fta, not you come of the sga has a 10 or 15 year history of violations for this country has shown itself to be unsafe. if you want to university system, this is too risky. don't they risk-based system for this company. in all honesty it should've been terminated by the sga up
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multiple transports on the way, 2002, 2004, 2006, 2008. i guess listening to your testimony today which you've been doing is collecting the data set some in congress finally passed a law to allow you to prevent this from happening you would then present it. is that what i'm understanding? do that complete and total authority to do anything at all even though the stuff happened? >> we worked very hard when the first problems at necc were identified with the state to address them aggressively, but our authorities around compounding pharmacies are limited. >> we been down this road before and were not buying it. in all honesty, he found evidence binder in front of you. top 15, look at it if you will.
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a letter dated october 31, 2008. the sga in writing to this compounding pharmacies a failure to do so may result in enforcement action including t-shirt the firm's product and or injunction against the firm and its principles. that's pretty strong language. now you lack the authority to do anything and you sent the letter like this? was the sent in error? it was an empty threat, is that what i understand? >> as was pointed out, i was not present at the fda and i cannot speak to the issues, but clearly there was an effort to assert authority around an issue very different than the issue about sterile compounds. >> this letter was issued in error that the fta sandisk and even those of previous administration, previous
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commissioner? >> in 2004, the fta was asked to take a look at an issue that involves specific products and whether or not necc was making inappropriately. >> with all due respect, our time is limited. i don't mean to be rude, but we've got to pursue this. did anyone at the fta get it because my mom saying he didn't have authority to do that so you better back off. >> the courts are split on what our authority -- >> may we at the committee have access to those internal memos but said he didn't have the authority to write that letter? >> that isn't what i said and i apologize if it came across that way. what i said is an inspection was done in response to a specific complaint and with respect to
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actions taken there was ambiguity in the law, >> let me try from another perspective if i could. we saw the company being graded from the computers thieves. did she do that and he didn't have authority to do that? >> you're asking me about one specific question that had to do with the warning letter, which is a discrete and different problem. >> pursue research and authority which you now tell us you don't have in that letter. >> you need to look at the math and see that the authority that is used to oversee compounding pharmacies is very fragmented. where different court decisions apply different regulatory frameworks to different parts of the country that cannot search stations well.
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we need to have a strengthen and clarify the legal regulatory authority that gives us some of the additional authorities. >> let me ask you a straightforward and simply, do you have the authority to regulate the manufacturer of these compounds are at the drug is druggists adulterated in some form, do you have that authority? >> we have many more authorities over jet manufacturers compounding pharmacies and that limits our ability to effectively ensure the safety and quality. >> let me ask in the simplest way i can. how many companies label this compounding pharmacies that ship 17,000 doses of sterile preservative free steroids every year? how many? >> we don't know how many compounding pharmacies are in fact engaging in those kinds of
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practices. what we do know is the industry has evolved and there are an increasing number of nontraditional compound errs who are in, for example, hospitals and clinics. >> we heard testimony from the widow of a big and you could tell there was bitterness in her voice against the clinic that provided the steroid injections. how can they buy from someone if they were sure? but i'm a doctor, you are, dr. smith, you are a physician. you take a file off the shelf, you make some assumptions as to his posters and see and durability. in this country, we stipulate because you've done your job at the fta we don't have to ask additional questions before we administer that to patient. now you tell me that is not the case and it? the authority to assert the
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safety and effectiveness of those medicines coming off the shelf is in fact valid? >> would have authority to oversee the safety efficacy and manufacturing. >> if you make 17 passes does this come your manufacturer. there is no other word for it. >> adjustments time is expired. let the record show, dr. hamburg, you have an obligation to answer yes or no. >> let the record show that dr. burgess asked to question time and time again and you would not answer yes or no. >> we do not have the authority. >> gentlelady from florida, ms. castor for five minutes. i'm sorry, nishikawa ski, welcome. >> i'm going to attempt to ask this question.
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this is for.or smith. in the aftermath of this tragedy, we have learned some troubling facts of the pharmacy and how it will look necc in the past and raises questions about whether the board was too close to necc and whether the board did enough to prevent conflicts of interest from effect to its decisions. so i wanted to ask you, dr. smith, one of the members of the board, i understand she is gone now. is that true? >> know, we've asked her to resign but she is declined. >> how long has she served on the board? >> i don't have that in front of me, but it has been several years. she was there in the previous administration. >> lettuce or affiliation with
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necc or its sister companies? >> she previously worked for necc -- i'm sorry, she started in the summer of 2004. she previously worked for necc and subsequently went to a company also owned by mr. katz. >> i understand she was vice president of regulatory affairs? >> yes, and the pharmacy records there. >> to she recuse herself from board actions related to these companies? >> and a review of the minutes of the board meeting, it is clear on several occasions there is a specific indication that she did herself. however, there are some minute silent on the issue don't say either way. because of the fact it was unclear she appropriately recused herself all boesch in an
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interview she declares he did because of the lack of clarity we ask her to resign, which as i said, she declined. >> i'm glad you're tempted to take action to remove her, but there's a lot of questions whether her will on the board during the time in massachusetts was receiving complaints softened the actions of the board that the board was going to take against necc. in 2004 after identifying significant problems, the board proposed a tough consent agreement with real sanctions. the something happened in the interim, the decree signed in 2007 was much weaker than the initial proposal. do you know how this happened and why the board proposed weaker penalties after they had received reports of problems at necc? >> we don't know how that happened nsa mentioned, attempting to find that out our
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interviews with her numbers about the precise issue has not yielded definitive information. most state they don't recall. >> was at the problems of the 2006 consent decree meant that it requires necc to be independently audited, but then necc to have significant input into evaluator with the? dr. smith, jay necc participate in its independent auditor and evaluator? >> well, we have been reviewing the records to try to determine who did make the final decision regarding the independent evaluator and it's unclear from documents we found who do do that. >> it's common for a party to select its own evaluator? >> i can't speak to whether it was common. you can certainly imagine that would be problematic, but we
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haven't determined -- >> is it still the practice? >> currently i'm not aware of any current actions involving outside evaluators. as we proceed as i mentioned we really look at the best practices around other states for the board of pharmacy, said there would be the kind of thing you would include. >> at the time psi with select to as an independent evaluator, one of the executives come across caputo is facing trial defrauding the fta and selling unapproved sterilization equipment to hospitals. the cause blindness by missing patients and who was later convicted. soon 2006, your agency sent a letter telling them to have satisfactorily completed the conditions of the consent agreement based on necc's compliance with the follow-up
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actions and identify the audit report of the company. is that correct? >> that is correct. >> were any massachusetts board of registration of pharmacy staff aware of the federal conviction when they found necc have satisfactorily completed recommended actions? >> as far as we can tell for interviews with staff and board members, they were not made aware of the fact that the primary evaluator had been convicted of federal crimes. the staff were aware and shockingly so do not share the information with the board. >> we've turned up a number of problems, but it seems that the necc was too close to the board and its members and it seems like the board was more interested in protecting pharmacists than protecting
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consumers. we have a lot of work to do, but it seems like some of the solutions we've laid out on the federal level for the fta are fairly clear and i'm hoping at the state level as well that these problems will get to the root of that. >> the gentlelady's time is expired. >> in your testimony he stated you've uncovered a number of problems were psi executives and others did not provide information to people. you have no evidence to indicate the board provided crucial information and get the board had to do something about the information. am i correct? >> is correct. >> you can break downs within the structure would've taken action to his people and found they were not properly informing her following rules. is there anything else within
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the law as you understand it that you have authority within massachusetts to pass information up to the fta if any of these problems occur? >> is nothing in practices or regulations i am aware of the required -- >> do you do it anyway? >> certainly since this investigation or episode has begun, we worked in partnership with the fda and have done all these factions together. that is an area essay mentioned when we move forward to determine what sorts of policies we should have about information sharing, if you should be required on a case-by-case -- >> is hopefully internally to identify this breakdowns, too. hamburg, is there someone who routinely interview state actions in your level when there's problems occurring, is
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there anyone who reviews anything with the state set out? >> there is not a system in statute or in this where there is that kind of back-and-forth communication on a routine basis. when there is a serious problem has occurred in this case, we mobilized into action very quickly. >> who is this mobilized to work with states? >> different components of fda depend on the nature of the problem. we have district offices and they are the first line in terms of identification of problems and responding. >> i'm trying to lay out a number of break downs of people are communicating with one another. i'm trying to find out within the fta, regardless of regulations come obviously someone has the authority to talk to state and i'm trying to find out if he's identified structural changes made within
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the fda to make sure you're communicating information coming to your desk for review. have you made any changes or reviews? >> part of the issue here is there are not firmly systems. there certainly are opportunities to improve communication, but it also is a broader issue. >> really, i'm trying to help and you're obfuscating. dr. smith and very cogent leadership says there's problems, identify the problems in the run-up after the problems. i'm trying to find out, you don't have to wait for authority to find out within the fta who can have the authority to review these things. do you have it, yes or no? >> i'm not sure what authority you mean. >> states in manufacturing, et cetera. >> when we do get reports, we have district offices and office of regulatory affairs. >> have you met with those people to review like
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>> yes, we work very closely with them. everyday there are issues that involve our work in the states. >> let me ask in terms of dealing with the definition of compounding pharmacy versus manufacturing, who within the fda is responsible for defining? >> well, it is not just fda. it is congress. >> who is the keeper of the definition -- >> our chief counsel's office. >> if you're viewed as chief counsel the definition of manufacture versus compounding? >> everyone agrees that the present time -- >> i did not set. please, please. i want to know, you said you counseled the definition of compounding versus manufacturing. have you reviewed without the someone? when did that take place?
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>> we've had many discussions. it crystallography that the manufacture versus compounding? >> i think unfortunately there is not a clear -- >> yes, there is because senior authority beutel is the crux of your test munged dacey don't have authority under manufacturing communists have never somebody told you at the definition of manufacture versus compounding is. i'd like to know who that is. or is it you? >> i really do think this is a broader issue. i nudge her first you by my answers and i'm sorry i can't give yes or no, but this is a complex issue. the course of our countries are split. >> that's not complex. complex is likely the 32 bit dems families have now. what you have to do is easy, man. children growing up without parents, people not having a spouse, that i submit to you is complex. leadership is easy if you're
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willing to accept it and you are not. dr. smith took leadership. she went in and clean house and identify problems. what you are telling me that saw the smoke and mirrors that you don't have authority. go look in the eyes of the victims and try to comfort them with that. man, that doesn't work. i bask in simple question and you can't even tell us if you talk to someone. >> i have told you we have been working very, very hard to apply the authorities we have to an evolving industry in situations where we do not have authorities we need. we don't even have registration at compounding facilities to know who they all are. there are no federal standards to which the compounding pharmacies are held in the courts have not -- i'm what is
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the big regulatory framework for examination and enforcement actions. i care deeply about the patients and their families. the mission of the fta to promote and protect how. we are as frustrated as you are that we don't have the authorities and resources. >> tell us the definition and bull moose from there. i yield back the >> the chair now recognizes ms. castor five minutes for questions. >> thank you for a match. i appreciate all of us coming together to focus on what we can do to prevent tragedies from ever happening again. i do think it is clear that there is great ambiguity in the law. fda, the law with regard to compounding pharmacies was last written in 1997.
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it is out of date and for my colleague from texas, there is ambiguity here, great ambiguity and has been made even more convoluted due to these court cases. i wish we would bring this up on the screen as well as the folks watching us at the hearing room can see it. in 1997, the congress passed the fda modernization act did that contained section 503 which dictated the circumstances under which compounded drugs were subject to fda regulation. and that law, congress six the fleetcenter compound or from oversight and regulation s. manufacturers. so i know that's what they're struggling with in trying to answer questions here. then the courts stepped in and this is where that to follow up on mr. terry's question about exactly which section? clarity and his request to direct to it.
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were talking about the entirety of section 503, aren't we? >> well, i have a three applies in some areas of the country and not in other areas, which is a very challenging situation. >> in 2001, the ninth circuit whose jurisdiction of the western state ruled the advertising component was unconstitutional and then sent the rest of five of three is inextricably tied to the advertising component. then a few years later in 2008, the fifth circuit court from the blue state to the south whose jurisdiction includes texas, louisiana and he will be unconstitutionality of advertising restrictions did not affect the rest and unfortunately, the united states supreme court did not write the tie to provide clarity.
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commissioner hamburg, what is compounded drugs as a result of these court decisions? >> it has created a very challenging situation, where we have contrasting legal regulatory framework for action. by the three applies some places. the other tool is our compounding guidance written in 2002, but that is not the force of law. it lays out our best thinking. >> it is very clear states had the day to day routine responsibility for overseeing compound. >> you have an industry that has evolved, but now some of the compound is when you think of the pharmacy on the corner, where it's very important that a lot of our neighbors get their customized compounded to. some of them now are sophisticated enterprises shifting all over the place and
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they've outgrown the 1997 law. so now we decide how we are going to update it to address the sophistication of compound or south are and then go after these bad at first because i think the majority are on the up and up living to high standards. but this is the map from the compounding industry and association and i'm afraid that if a to some of the bad act as being able to take advantage of the situation and gaps in regulatory authority. is that a good summary? >> that is an excellent summary and i appreciate your trying to help me explain this because it is an extraordinary complex situation, where the effort -- >> i don't think it is overly complex. i think there is a difference in
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outlook on whether you have certain authority and i think it's clear under this law and court cases under this law and court cases under this law and court cases to acting clarify it and it's got to to acting clarify it and it's got to be additional oversight of the state. if they're going to drop the ball and they're not going to provide proper oversight, then it's time for the feds to step in and give fda the tools it needs to prevent tragedies from ever happening again. thank you had i yield back. >> i don't know if i'm allowed to make a comment, but speaking to the complexity of the issue and the changing, evolving industry overlaid on top of the front end to in ambiguous legal framework, it is important to understand this notion of the back of my compound or a
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manufacture is trying to set a square peg into a round hole and in fact, if the law is examined, it isn't really adequately defined. but this area of outsourcing pharmacies that is increasing the important and medical practice. if we were to find all the pharmacies and hospitals use. dr. burgess, you would appreciate this. it used to be that the hospital would add to potassium chloride to the iv bag in their basement pharmacy and give it to the patient. not because the volume and concerns about making sure it's under the best possible practices, that is outsourced to a pharmacy. they are making a product in larger volume and often not
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making it with a patient prescription in hand. yet it is clearly serving an important medical needs. and if we were to treat them as drug manufacturers, that would be simply impossible. but how to submit a formal application to fda for review and action. they have to pay fees associated with that as well. they would have to be subject to the ineffectual part this. so i think we want to work together to make sure we have a thought that clearly defines critical issues and authorities that enable important patient needs to be addressed, the clarify the different roles and responsibilities and puts in place critical the third is currently misled. a >> i'm going to interview there in the interest of time. dr. kingery is recognized for five minutes for questions, sir.
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>> mr. question, thank you very much. an extremely interesting important hearing, tragic in so many ways of the lab's last end the number of cases of meningitis sisters out of this bad actors. dr. hamburg, dr. smith, we appreciate you being here as some of the line of questioning of both sides of the diocese republicans and democrats have been tough, but they have to be because before going to change the law, reread the federal food, drug, cosmetic act in regard to section by the 3a and the thickness of the section in the conflict in court decisions, we have to get this right. i have some great concerns that we might not get it right in regard to overreacting and
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regulating compounding pharmacies. every member of the house of representatives have drugstores in their matching drugstores. a lot of them just to compounding, where certain products as needed by a patient, but maybe to manufacture product is in eight days or something and they are allergic to come and sit there for the local pharmacist has to reconstitute the drug, not manufacture. the drug is manufactured. just put it in a different way of giving it to the patient. it might even be an appellate form. think hormone replacement eric p. in some cases are a vanishing cream or intimidation is not allergic to. if we get to the point in the line of questioning that
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dr. hamburg received from a long-standing member of meredith, mr. dingell, about compounding pharmacy, it worries me a little bit we might overreacting due to the point that we are not getting at the problem. it seems to me that this particular company, and assuming glenn compounding company was an unusually bad actor, and usually egregious than i would be very surprised if there are not multiple lawsuits in the final analysis and service of jail time. again, i can't understand why.or smith, i'll direct this to you. i realize it's only been in this position and by all appearances and from what i've read and this company is going back to 1998
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and a bright light has been shining on the police and 2002 and there has to be some connection between members of this massachusetts farmers ignored from a period of time and i think we've got evidence there was some cross-pollination where it may be one of these individuals served on the board of the newly glenn compounding center, one of the sister companies. it's just unbelievable that the general public is so disgusted with washington. we look at what's going on at the highest level of paramilitary and the situation during the 21st century we've got a food and drug
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administration to make that state pharmacy board the sub and the this can happen is almost beyond belief. it makes me think back to what president reagan said in reference to the russians in their nuclear stop file to trust but verify. and that's the responsibility of this oversight and investigations subcommittee on energy and commerce. trust but verify. we are not trusting today as you can tell from a line of questioning. and we shouldn't be. that judge in the previous panel talk about contribution to society in the great state of tennessee and his life was lost, but a vicious one how many? were talking about far too many people. so i was just in my last second asked you, dr. hamburg and maybe
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dr. smith to comment as well, do you think that the fda needs because of this develops a sudden high price change the law so that you are ever succeeds you have says broad authority over the compounding pharmacies across the country who are doing the right thing. they're not manufacturing drugs. they're just trying to provide a service based on a prescription that has to be written. this company was an absolute cricket operation and they kill people. i don't think anybody should get confused between them and the typical compound pharmacy in drugstores across our districts. >> we need a tiered approach in terms of the legislation. i think that clearly the traditional compound or working
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locally is overseen by the state. but this is a sadly an isolated incident. this is the worst and most tragic and you should be the last wake-up call to ask him about. now almost two decades, there have been problems with compounding facilities, compounding pharmacies and i think it reflects this gap in regulatory oversight and the fact that we really need a strong, clear and appropriate legislation. we cannot have a crazy quilt, were different parts of the country are subject to different legal frameworks for oversight. we need a tiered system that recognizes the role of compounding and the role of state, nontraditional and there
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should be federal standards in me to look at a site of statutorily based criteria from the fact is that in some combination of the people into this category. the type of product or activity, sterile processing, tomato products being made, whether it's in interstate commerce, whether it's going directly to the end-user or to a third party in the nature of the anticipatory compounding. and then something should simply shouldn't be compounded, that should be manufactured by a drug manufacturers subject to the full force of fda authorities and that would include come you know, certain things are well familiar, trance terminal, biologic and other products that because of the nature of the manufacturing they really should
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be made in accordance with good manufacturing practices. they should be subject to the ft preapproval review for safety, efficacy. >> thank you. i've gone way beyond my time. i appreciate the chairman's indulgence. >> thank you, mr. chairman. i think the questions in the testimony today show from all three panels the problem we have the necc live there every grocery gap between the practice of traditional pharmacy compounding and full-scale drug manufacturing. there's no debate with the federal government to license after state responsibility, nor is there a debate whether fda should oversee a large-scale in a bipartisan basis of what we've heard. there's overwhelming numbers of signals about necc, which is not your average neighborhood pharmacy. commissioner smith, how many
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different states did necc sell products to? >> i'm not sure about all the products that >> did they sell in massachusetts? be my guess, they did. >> 23 states. do they sell products in the massachusetts market? >> yes. >> company states to defend the contaminating injections? >> i was 23. >> necc was not to the nationwide strike team. had they been operating throughout the country for about a decade? the massachusetts board of pharmacy had gotten complaints and troubling signs around the country are the old period of time. the board received complaints from idaho in new york for necc was inappropriately soliciting business. the fourth estate report from south dakota resending blank forms burgess besides that she never use someone or send via
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the board received adverse event reports from products from florida and new york in the board receives complaints from pharmacists in texas and iowa for necc with soliciting prescriptions for the board received reports of cease and desist order in colorado. or smith, red flags came across the country and i can go to the list of states again. wasn't it obvious that necc is operated on a large scale of the nationwide program of greater involvement by the federal government? >> yes. >> to the board a massachusetts request assistance from the fda? >> i am not aware of any specific requests. however, during the most recent outbreak we worked together. >> they been doing this for 10 years and you will have represented. tg shared records that the fda? those complaints? >> i'm not aware. i do not recall.
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>> i think that's our problem. i've been on the committee since 97. we never included federal regulation or compounding pharmacies because frankly that's licensing that state. but when they are the manufacturing situation, which they are, but the should of been covered by federal law. i know it's complicated and hard for a doctor to explain the legal. it's hard for a lawyer to explain legal. i think we have a bipartisan agreement. the subcommittee does into legislation, but believe me, the health subcommittee can. i don't know if we can do it by the end of the terms and i know our chairman is not here, but i would hope a good look at a quick piece of legislation. we could have a series to correct this problem. because if you are a compounding manufacturing texas, brought to the be federal law. i don't expect your local pharmacy board in texas -- they go around and inspect my pharmacists, whether they be
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large pharmacists at walgreens for cvs. i don't write a tear or a neighborhood pharmacist. but they don't inspect necessarily the compounding manufacturers and that is where federal law needs to come in. i'm glad to yield to my colleague and i hope we would see movement on the bill on a bipartisan basis. >> thank you. let me ask you this, dr. hamburg. when you inspect compounding drugs you get sued by the compounding industry? >> we have been sued on numerous occasions. we've been challenged in terms of our authorities. >> when you try to regulate compounded drugs, new drugs, you get sued? >> we do not. the authority there is very clear. expectations on drug manufacturers in terms of what they need to do to comply with fda law. >> when you request documents from compounding firms, do they
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still? >> you know, we often have to go to the courts and get warrants in order to get the materials we need. we do not have the full authority that we need to review documents. >> when you ask a drug company, when you request documents from none, do they go to court? >> no, we have much clear authority server to any fracturing. >> when you're inspecting merck, do they question your authority to inspect? >> they do not. >> asked why the fda needs authority because it's clear the drug companies except the law. >> as much as i grit my colleague of massachusetts, i yield back my time, but i hope her committee hearing is done what we need to do. >> i think his comments were very per at a bipartisan and i appreciate that. do you think in your heart of hearts that the energy and
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commerce and health subcommittee should provide more regulation authority to the fda before the end of the year? >> i thought we had to respond to the tragedy that happened. i think we ought to the families, but also thousands of people who may not have been subject to a death in the family, but an illness because of practices that this particular compounding company that happens to be in massachusetts. it could've been in any other state. massachusetts did have warning. there were complaints for 10 years about it and i hope we would have utters interstate sharing between the states and federal regulatory agency even though it may not have had the authority, but somehow it tenures they could have come and get it earlier. >> the gentleman from virginia, mr. practice for five minutes. >> obviously this is very frustrating. i would like to know what kind of due diligence the fda has the authority to do. do send letters to dock areas
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from the same are you getting your compound medicines from? or where are you getting supplies from? the reason i ask that in the same thing for hospitals or clinics or other medical providers is because this was not what we think of as compounding. this was manufacturing. in my small area, which overlaps the new river valleys, we have compiled a list of approximately 1415 patients who were advised based on press reports. they were notified they could have been exposed to fungal meningitis or the steroid injections and other products by the new england compounding center. we have a hospital but didn't fortunately use it, that had it sitting on the shelf. we had -- that was the korean jugs community hospital. but that site imogene in roanoke
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river valley. but other clinics including do a spell medical center in salem, all of which had these products. look, i don't represent new york city. this is fairly compared to other parts of the country, a fairly small area and we've got 1415 people who have to worry about whether or not they're going to get the disease. we have more than that to have already contracted it, roughly 50 confirmed cases in the area, three signs that were crossed by west virginia, but not that far from our medical centers. and when you've got that many folks affected, we're not going with with the compound are come which is why it's frustrating when you keep going that jurisdiction is not clear. your jurisdiction was clear. these folks were manufacturing. but due diligence did you take
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to find this out? these aerobic operations committee sent a letter saying who is providing you with various products, you know, they would've complied and you would have been -- fta, not you, did some work back under the bush administration. and it appears there is no due diligence going on to chew on were saying, who is providing you with the stuff? with the colorado vault, tennessee involved, who make complaints in advance. we've got 1415 people in my district are bob goodlatte's predominantly. you know, somebody wasn't paying attention. this was not your small compounding pharmacy. these were any fractures and i recognize they were violated moskovitz frustrated when you come in and say authority with the courier. what are you do

Tonight From Washington
CSPAN November 14, 2012 8:00pm-11:00pm EST

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TOPIC FREQUENCY Fda 85, Necc 49, Massachusetts 46, Us 27, Hamburg 20, Dr. Smith 19, England 11, Colorado 9, Michigan 7, Fta 7, Ms. Lovelace 6, Smith 6, Kentucky 5, Joyce Lovelace 5, Barry Cadden 5, Texas 5, Joyce 4, Mr. Dingell 4, Tennessee 3, Albany 3
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